Study of the usefulness of treatment of fungal infections in children with cancer and compromise of their immunity

Efficacy of pre-emptive versus empirical antifungal therapy in children with cancer and high-risk febrile neutropenia: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-3m9d74

Enrollment

Unknown

Registered

2018-07-05

Start date

2013-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile neutropenia

Interventions

compare the efficacy of pre-emptive versus empirical antifungal therapy in children with cancer, fever and neutropenia. Experimental group (Pre-emptive): 76 children with persistent fever and neutrope

Procedure/surgery

C01.539.757.360

D27.505.954.122.136

Eligibility

Age

1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Children and adolescent with cancer; less or equal to 18 years of age; admitted because of a febrile neutropenia episode. Informed consent of the parent or legal guardian assent if older than 8 years of age.

Exclusion criteria

Exclusion criteria: Children with hematopoietic stem cell transplant. Children with cancer under voriconazole or posaconazole prophylaxis.

Design outcomes

Primary

Measure	Time frame
Overall mortality at day 30 of follow-up. Expected primary outcome: overall mortality at day 30 of follow up of 6%.;Observed primary outcome: overall mortality at day 30 of follow up was 6,7% (10/149).	—

Secondary

Measure	Time frame
Invasive fungal disease related mortality (number, percentage). ;Number of days of fever, number of days of hospitalization and number of days of antifungal use.;Percentage (%) of episodes that developed an Invasive fungal disease.;Percentage (%) of episodes requiring modification of initial treatment strategy.;Percentage of episodes requiring admission to the Intensive Care Unit.	—

Countries

Chile

Contacts

Public ContactMaria Elena Santolaya

Universidad de Chile

msantola@med.uchile.cl+56222352075

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 5, 2026